BEUDAMED
    FDA Adverse Event Other Summary report: N

    500-D & 1000-D URINARY DRAINAGE BAG

    MDR report key: 888278 · Received July 31, 2007

    Report

    Report Number
    1056553-2007-00002
    Event Type
    Other
    Date Received
    July 31, 2007
    Report Date
    July 26, 2007
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1056553-2007-00002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 28, 2007, PRODUCTS WERE RECEIVED IN FROM OUR SUPPLIER WITH CERTIFICATE OF STERILITY AS REQUIRED BY INCOMING INSPECTION SPECIFICATIONS. BECAUSE THIS WAS ONLY THE 2ND ORDER TO BE RECEIVED FROM THE SUPPLIER, REMINGTON MEDICAL REQUIRED VERIFICATION OF THE STERILITY THUS, SAMPLES WERE SENT TO OUTSIDE TESTING LABORATORY. ON JULY 20, 2007, THE TESTING FACILITY REPORTED, THE PRODUCT SAMPLES HAD BACTERIAL GROWTH. A FIRM INITIATED RECALL WAS INITIATED AS A RESULT OF THE TEST RESULTS.

    Description of Event or Problem · 1

    DRAINAGE BAGS WERE DISTRIBUTED UPON RECEIPT OF SUPPLIER'S CERTIFICATE OF STERILITY TO VARIOUS CUSTOMERS. PRODUCT SAMPLES WERE SENT TO 3RD PARTY STERILITY VERIFICATION. ON JULY 20, 2007, TESTING LABORATORY NOTIFIED COMPANY OF POSITIVE TEST RESULTS. AS A RESULT OF CONTACTING THE FACILITIES, WHERE PRODUCT WAS DISTRIBUTED, COMPANY WAS NOTIFIED OF 2 PATIENTS AT DIFFERENT FACILITIES THAT HAVE DEVELOPED URINARY TRACT INFECTIONS. IN BOTH CASES, THE FACILITY STATED THAT THERE WAS NO WAY TO DETERMINE IF THE INFECTION WAS A RESULT OF THE DRAINAGE BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 500-D & 1000-D URINARY DRAINAGE BAG URINARY DRAINAGE BAG KNX REMINGTON MEDICAL, INC. 500-D 20070423

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other